Cleared Traditional

K932878 - PRECISION INTRA-ORAL SCOPES

K932878 is an FDA 510(k) clearance for PRECISION INTRA-ORAL SCOPES, manufactured by Precise Optics. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K932878 · Precise Optics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
206d
Days
Class 1
Risk

K932878 is an FDA 510(k) clearance for the PRECISION INTRA-ORAL SCOPES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Precise Optics (Gardner, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 206 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Precise Optics devices

FDA 510(k) Submission Details - K932878

510(k) Number K932878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date January 06, 1994
Days to Decision 206 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 127d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 189
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K932878.
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K933167 · A-Dec, Inc. · Oct 1993
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K933163 · A-Dec, Inc. · Oct 1993